The US FDA’s Center for Drug Evaluation and Research approved four novel agents over the last two weeks, split between new approaches in crowded disease states (two different bispecific antibodies for triple-class refractory multiple myeloma from Pfizer Inc. and Johnson & Johnson) to the first-ever treatments for orphan diseases from Ipsen SA (Sohonos for fibrodysplasia ossificans progressiva) and Regeneron Pharmaceuticals, Inc. (Veopoz for CHAPLE syndrome).
The FDA issued two priority review vouchers (PRVs) for rare pediatric disease therapies this month. The vouchers for Regeneron’s Veopoz...
